FDA Center for Drug Evaluation and Research Director Janet Woodcock expects the agency's new-drug approval rate to hold steady or increase, and says human genome sequencing will bolster the industry, according to SVB Leerink. Woodcock says the FDA is embracing new methods to generate data, such as basket trials and adaptive design, and is incorporating patient goals and preferences into review and approval decisions.
Woodcock: FDA adapting to new clinical trial models, patient goals
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